{"product_id":"beckman-coulter-calibrator-access-r-sars-cov-2-igm-2-x-2-ml-for-use-in-calibration-of-access-sars-cov-2-igm-assay-on-access-family-of-immunoassay-systems-only-liquid-m-1172372-2205-box-of-1","title":"Beckman Coulter Calibrator Access® SARS-CoV-2 IgM 2 X 2 mL For use in Calibration of Access SARS-CoV-2 IgM Assay on Access Family of Immunoassay Systems only Liquid - M-1172372-2205 - Box of 1","description":"\u003cp\u003e\u003cspan style=\"color: #ff0000;\"\u003e\u003cstrong\u003eItem is Non - Returnable\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\u003ch3\u003e\u003cstrong\u003e\u003cspan style=\"color: #ff0000;\"\u003eDelivery - 7-10 Days, Ship Directly from Manufacturer\u003c\/span\u003e\u003c\/strong\u003e\u003c\/h3\u003e\u003cli\u003eThe Access SARS-CoV-2 IgM Assay is only for use under the FDA's Emergency Use Authorization: https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/emergency-use-authorizations\u003c\/li\u003e \u003cli\u003eTesting is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests\u003c\/li\u003e \u003cli\u003eAccess SARS%XE2%X80?CoV%XE2%X80?2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS%XE2%X80?CoV%XE2%X80?2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate)\u003c\/li\u003e \u003cli\u003eAccess SARS%XE2%X80?CoV%XE2%X80?2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS%XE2%X80?CoV%XE2%X80?2, indicating recent or prior infection; at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.\u003c\/li\u003e \u003cli\u003eLaboratories within the United States and its territories are required to report all results to the appropriate public health authorities\u003c\/li\u003e \u003cli\u003eThe sensitivity of the Access SARS-CoV-2 IgM assay early after infection is unknown; negative results do not preclude acute SARS-CoV-2 infection\u003c\/li\u003e \u003cli\u003eFalse positive results for the Access SARS%XE2%X80?CoV%XE2%X80?2 IgM assay may occur due to cross%XE2%X80?reactivity from pre%XE2%X80?existing antibodies or other possible causes; due to the risk of false positive results, confirmation of positive results should be considered using a second different assay\u003c\/li\u003e \u003cli\u003eThe Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systemsonly\u003c\/li\u003e \u003cli\u003eThe Access SARS-CoV-2 IgM Calibrators are provided as: negative and positive; assay calibration data are valid up to 28 days\u003c\/li\u003e \u003cli\u003eProvided ready to use\u003c\/li\u003e\u003cbr\u003e \u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e\u003ctbody\u003e  \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e1172372\u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003eMF ID\u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003eC58958\u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003eBrand\u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003eAccess®\u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003eManufacturer\u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003eBeckman Coulter\u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Application \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Calibrator \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Container Type \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Vial \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e For Use With \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e For use in Calibration of Access SARS-CoV-2 IgM Assay on Access Family of Immunoassay Systems only \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Form \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Liquid \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Levels \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Level 1, 2 \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Product Dating \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e McKesson Acceptable Dating: we will ship \u0026gt;= 30 days \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Storage Requirements \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Requires Refrigeration \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Test Name \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e SARS-CoV-2 IgM \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Test Type \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Antibody Test \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e UNSPSC Code \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e 41116145 \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Volume \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e 2 X 2 mL \u003c\/td\u003e   \u003c\/tr\u003e  \u003c\/tbody\u003e\u003c\/table\u003e","brand":"Beckman Coulter","offers":[{"title":"Box of 1","offer_id":39988329414845,"sku":"M-1172372-2205","price":492.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/axiommedicals.com\/products\/beckman-coulter-calibrator-access-r-sars-cov-2-igm-2-x-2-ml-for-use-in-calibration-of-access-sars-cov-2-igm-assay-on-access-family-of-immunoassay-systems-only-liquid-m-1172372-2205-box-of-1","provider":"Axiom Medical Supplies","version":"1.0","type":"link"}